Browse Drug Recalls
1,076 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,076 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 1,076 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 26, 2025 | Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, ... | Presence of Foreign Tablets/Capsules | Class II | Golden State Medical Supply Inc. |
| Nov 17, 2025 | Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Phar... | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, ... | Class II | Preferred Pharmaceuticals, Inc. |
| Oct 20, 2025 | SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Wo... | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. | Class I | ANTHONY TRINH, 123Herbals LLC |
| Oct 20, 2025 | NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx onl... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Oct 10, 2025 | Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottl... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, ... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50, Zinc Oxide 21... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) p... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Sea Enzyme Ultra Umbrella Sunscreen SPF 30, Titanium Dioxide 4%, Octinoxate 4... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel with Menthol and Ar... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | CLEARSTEM YOU ARE SUNSHINE SPF 50, Zinc Oxide 21%, 2.1 oz/61g per bottle, Dis... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g pe... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% an... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor D. Schwab Controlling Balm with Tea Tree Oil, Salicyclic Acid 0.8%, 1 ... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Doctor D. Schwab Controlling Cream, Benzoyl Peroxide 2.7%, 1 FL OZ/ 30 ML per... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 O... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz ... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Oct 10, 2025 | Karina Daily Moisturizer SPF 25, Octinoxate 7.5% and Zinc Oxide 7.0%, Net WT.... | CGMP Deviations | Class II | CA BOTANA International, Inc. |
| Sep 12, 2025 | Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl P... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 ... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Sk... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverl... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) ... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Aug 28, 2025 | Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count... | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil | Class I | Green Lumber Holdings, LLC |
| Jul 1, 2025 | PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated... | Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identifi... | Class II | Central Admixture Pharmacy Services, Inc (CAPS)... |
| Apr 28, 2025 | temper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by:... | CGMP Deviations | Class II | Siddha Flower Essences, LLC. |
| Apr 18, 2025 | Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufacture... | cGMP Deviations | Class II | Preferred Pharmaceuticals, Inc. |
| Apr 15, 2025 | Dexonto 0.4% (dexamethasone sodium phosphate) solution 20 mg/5 mL (4 mg/mL), ... | Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are ... | Class II | Nubratori, Inc |
| Mar 31, 2025 | 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL... | Presence of Particulate Matter | Class II | B. Braun Medical Inc |
| Mar 7, 2025 | Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister c... | Defective Container: blister packs not properly sealed resulting in tablets being loose in the ca... | Class II | ASEGUA THERAPEUTICS LLC |
| Mar 5, 2025 | PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorp... | Failed Dissolution Specifications | Class II | Golden State Medical Supply Inc. |
| Feb 27, 2025 | Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL si... | Stability data does not support expiry: the products have the potential to be out of specificatio... | Class II | Amgen, Inc. |
| Feb 27, 2025 | Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx ... | Stability data does not support expiry: the products have the potential to be out of specificatio... | Class II | Amgen, Inc. |
| Dec 16, 2024 | FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Di... | Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with und... | Class I | SHOPPERS- PLAZA |
| Nov 22, 2024 | 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your R... | CGMP Deviations: Inconsistency in the water systems. | Class II | Generitech Corporation |
| Nov 4, 2024 | ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomM... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... | Class I | Boulla LLC |
| Nov 4, 2024 | PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distribut... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... | Class I | Boulla LLC |
| Nov 4, 2024 | VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Dist... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... | Class I | Boulla LLC |
| Nov 4, 2024 | ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclof... | Class I | Boulla LLC |
| Oct 8, 2024 | AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, | Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class II | C & A Naturistics |
| Sep 24, 2024 | Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Ma... | Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in... | Class II | Nivagen Pharmaceuticals Inc |
| Sep 19, 2024 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... | Presence of Particulate Matter: Presence of glass particle. | Class I | Gilead Sciences, Inc. |
| Sep 18, 2024 | Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sd... | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone ... | Class I | 123Herbals |
| Aug 28, 2024 | BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML... | Microbial contamination of non-sterile Products - | Class II | PREQUEL SKIN |
| Aug 8, 2024 | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bo... | Failed Impurities/Degradation Specifications - at 18-month Stability testing | Class II | Preferred Pharmaceuticals, Inc. |
| Jul 24, 2024 | 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Brau... | Presence of Particulate Matter | Class I | B. Braun Medical Inc |
| Jul 18, 2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... | Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Dicl... | Class I | MAIN PRODUCTS INC |
| Jul 12, 2024 | Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in ... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared D... | Class I | SoloVital |
| Jun 24, 2024 | SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, ... | Sub-potent Drug | Class III | Neilmed Pharmaceuticals Inc |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.